Up to two leads, lead protection boots, and burr hole covers may be implanted. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. Safety and effectiveness of neurostimulation for pediatric use have not been established. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Patients who are unable to properly operate the system. Electromagnetic interference (EMI). Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). Equipment is not serviceable by the customer. If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. High stimulation outputs. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. Therapeutic radiation. This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II.**. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. The system is intended to be used with leads and associated extensions that are compatible with the system. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Avoid excessive stimulation. Damage to shallow implants. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Patient training. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Diathermy is further prohibited because it may also damage the neurostimulation system components. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Make the Bold Choice Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. Device modification. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). Consumer goods and electronic devices. away from the generator and avoid placing any smart device in a pocket near the generator. Clinician training. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Do not use surgical instruments to handle the lead. Activities requiring coordination. All components listed must be implanted unless noted as "optional." When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Placement of lead connection in neck. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Using surgical instruments. Use extreme care when handling system components. Patients should exercise reasonable caution when bathing. Application modification. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Lead movement. Patient activities and environmental precautions. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Wireless use restrictions. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Pregnancy and nursing. Return any suspect components to Abbott Medical for evaluation. Security, antitheft, and radiofrequency identification (RFID) devices. Physicians should also discuss any risks of MRI with patients. Return of symptoms and rebound effect. If unpleasant sensations occur, the IPG should be turned off immediately. Follow proper infection control procedures. Confirm the neurostimulation system is functioning. This equipment is not serviceable by the customer. Overcommunicating with the IPG. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Use care when reinserting a stylet. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 Approved models and implant locations for an MR Conditional lead-only system. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. PATIENTS If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Transcutaneous electrical nerve stimulation (TENS). Store components and their packaging where they will not come in contact with liquids of any kind. Keep them dry to avoid damage. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Anchoring leads. While charging the generator, patients may perceive an increase in temperature at the generator site. Set the electrosurgery device to the lowest possible energy setting. Pediatric use. Explosive and flammable gasses. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. Keep dry to avoid damage. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. Clinician programmers, patient controllers, and chargers are not waterproof. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Implantation of two systems. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated. Low frequencies. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Damage to the system may not be immediately detectable. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. FDA's expanded . Poor surgical risks. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Before reinserting the sheath, verify there is no damage to the sheath. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Patients should be advised to not use therapeutic magnets. Always perform removal with the patient conscious and able to give feedback. Skydiving, skiing, or hiking in the mountains. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. PDF View Shellock R & D Services, Inc. email: . Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. If the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Operation of machines, equipment, and vehicles. Keep programmers and controllers dry. Poor surgical risks. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. Implantation of multiple leads. Output power below 80 W is recommended for all activations. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. Sheath retraction. Component manipulation. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. Wireless use restrictions. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Free from the hassles of recharging. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 2013;16(5):471-482. To prevent injury or damage to the system, do not modify the equipment. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. The system is intended to be used with leads and associated extensions that are compatible with the system. Unwanted changes in stimulation may include a jolting or shocking feeling. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Battery precaution. Pregnancy and nursing. Package or component damage. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Damage to the system may not be immediately detectable. Exposure to body fluids or saline. To prevent unintended stimulation, do not modify the operating system in any way. If lithotripsy must be used, do not focus the energy near the generator. Consumer goods and electronic devices. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Clinician training. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Care and handling of components. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. ** To prevent injury or damage to the system, do not modify the equipment. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . If interference occurs, try holding the phone to the other ear or turning off the phone. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Security, antitheft, and radiofrequency identification (RFID) devices. The force of the instruments may damage the lead or stylet. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Return any suspect components to Abbott Medical for evaluation. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). If needed, return the equipment to Abbott Medical for service. IPG placement. Stabilizing the lead during insertion. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Return them to Abbott Medical for proper disposal. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Generators contain batteries as well as other potentially hazardous materials. Neurosurgery Pain Management Orthopaedic Surgery Handle the programmers and controllers with care. Radiofrequency or microwave ablation. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. Patients should cautiously approach such devices and should request help to bypass them. Return the explanted IPG to Abbott Medical. six to eight weeks after implantation of a neurostimulation system. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. System testing. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Only apply software updates that are published directly by Abbott Medical. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes.